Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-01-31 @ 7:47 AM
Study NCT ID:
NCT02823561
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2016-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Garcinia Mangostana Extracts in the Management of Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2016-06-23', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss - Kg reduction', 'timeFrame': '26 weeks'}], 'secondaryOutcomes': [{'measure': 'Insulin sensitivity assessed by the homeostatic model assessment (HOMA-IR)', 'timeFrame': '26 weeks'}, {'measure': 'Lipid profile by serum biochemistry', 'timeFrame': '26 weeks'}, {'measure': 'Abdominal obesity measured by waist circumference', 'timeFrame': '26 weeks'}, {'measure': 'Body composition by Dexa parameters', 'timeFrame': '26 weeks'}, {'measure': 'Changes in microalbuminuria by unin analysis', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Severe Obesity']}, 'descriptionModule': {'briefSummary': "Obesity is one of the greatest public health challenges of the 21st century. Its prevalence has tripled in many countries of the European Region since the 1980s, and the numbers of those affected continue to rise at an alarming rate. In addition to causing various physical disabilities and psychological problems, excess weight drastically increases a person's risk of developing a number of noncommunicable diseases including cardiovascular disease, cancer and diabetes, in association or not to metabolic syndrome. The risk of developing more than one of these diseases (co-morbidity) also increases with increasing body weight. Every year a growing number of patient tend to suffer of more severe obesity and difficulty in losing weight even with a restricted diet and exercise.\n\nGarcinia mangostana (Sphaeranthus indicus extract) has known for its antioxidant properties; new evidence point out some promising effects in the prevention of lipogenesis and the promotion of lipolysis . Currently in the scientific literature there is only one paper, by Stern et al., showing the association of Garcinia mangostana assumption in low-calorie diet. This work has demonstrated a significant reduction in weight loss , compared to the placebo group,due to the use of Garcinia mangostana.\n\nAim of the present study is the evaluation of safety and efficacy of weight loss in severe obese patients. Also cardiometabolic parameters and flogosys serum indicators will be evaluated before and after 6 month therapy of low calory diet alone or in association with Garcinia mangostana extract.", 'detailedDescription': 'After the screening visit for the evaluation of the inclusion / exclusion criteria and sign informed consent(Visit 1), each patient will be randomized (Visit 2; Time 0; Baseline) (1: 1) to receive two different treatment for the duration of 26 weeks:\n\n1. low-calorie balanced diet consistent exercise (control group)\n2. balanced low-calorie diet and regular exercise in combination with the assumption of Garcinia mangostana (treatment group)\n\nThroughout the duration of the study, every eight weeks, unless otherwise indicated from the specialists, for each subject was expected a nutritional and an endocrinological visit with a anthropometric parameter check (body composition) and compliance to therapy (dietary / physical activity diary).\n\nAlso a bood sample test was performed to evaluate electrocardiogram, lipid profile, glucose tolerance, hormonal parameters, inflammatory and bone markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity: BMI \\>35 kg/m2.\n* Stable medical therapy for comorbidities from at least 6 months\n\nExclusion Criteria:\n\n* Hormonal replacement therapy\n* Hyperprolactinaemia and /or other endocrine hypothalamic-pituitary diseases (empty sella syndrome and expansive pituitary disorders evaluated by MRI)\n* Any other condition that medical judgment precludes patient safety'}, 'identificationModule': {'nctId': 'NCT02823561', 'briefTitle': 'Garcinia Mangostana Extracts in the Management of Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Efficacy and Tolerability of Garcinia Mangostana Extracts in the Management of Weight Loss in Severe Obese Patients', 'orgStudyIdInfo': {'id': 'URomLS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Garcinia mangostana (treatment group)', 'description': 'Balanced low-calorie diet and regular exercise in combination with integration', 'interventionNames': ['Dietary Supplement: Garcinia mangostana']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'balanced low-calorie diet and regular exercise', 'interventionNames': ['Behavioral: Control group']}], 'interventions': [{'name': 'Garcinia mangostana', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Garcinia mangostana (treatment group)']}, {'name': 'Control group', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Carla Lubrano', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}